Nature: How Facebook and Twitter could be the next disruptive force in clinical trials

[Kalliope]

Interesting feature on a topical issue. It's getting easier for patients that participates in clinical trials to connect online and share experiences and information. But what if that leads to unblinding a trial?
Also discusses how difficulties in recruiting patients for clinical trials has led to more usage of patient-advisory boards giving feedback on trial designs.

Heidi Ledford: How Facebook and Twitter could be the next disruptive force in clinical trials

“Part of the balance is recognizing that although good science is great, it also has to be feasible and convenient,” says Getz. “That’s where patient engagement has completely changed the philosophy.”

 

[alex3619]

But what if that leads to unblinding a trial?

There was a clinical trial I heard of where this happened mid-trial, back in the 90s or 80s I think. The entire trial was cancelled.

 

[Kalliope]

There was a clinical trial I heard of where this happened mid-trial, back in the 90s or 80s I think. The entire trial was cancelled.

Already back then? And now it's even easier to find fellow participants and share notes.

 

[inox]

Online discussions threaten to compromise trial integrity when participants join forces to work out who is receiving a placebo. Discussing potential side effects can also influence results, particularly when the symptoms are subjective. Drug companies have yet to report any cases of such actions causing irrevocable damage to a trial, but some researchers worry that information-sharing by participants could sink trials or weaken their findings.

This was a concern Fluge and Mella had with the rituximab trial. Both the risk that patients would unblind themselfs, and knowing there were proponents of the trial that would have loved something to dismiss results with (if the trial had a positive outcome).

They asked the participants not to discuss the trial/symptoms/side-effects online, and both participants and the wider online community took responsibilty in not doing so. At the time there was also a private clinic selling rituximab-treatment, and patients that chose to go there made their own, secret/hidden facebook grops to disuss among themselfs, without risking disturbing the trial.

Maybe it would have been different if we were spoiled with lots of treatment trials? But enganging with the patient community and remind people why it's important to the science not to discuss and speculate did make a difference.

 

[rvallee]

Oh, so unblinded trials are a problem now? Or is that only an issue when it does not confirm bias?

I'd really love for unblinded-trials-are-a-problem to come back, it's been a complete trainwreck. And not arbitrarily applied.

 

[alex3619]

Already back then? And now it's even easier to find fellow participants and share notes.

They often turn up in the same waiting rooms and get to talking.

 

[Barry]

Oh, so unblinded trials are a problem now? Or is that only an issue when it does not confirm bias?

The problem will be where properly designed blinded trials, then become unblinded. They were never designed to be unblinded.